A Randomized Double-Blind Placebo-Controlled Study to Evaluate the Efficacy and Safety of Volixibat in the Treatment of Cholestatic, Pruritus in Patients with Primary Sclerosing Cholangitis (VISTAS)
VISTAS - A Clinical Research Study for Primary Sclerosing Cholangitis (PSC)
Sponsor: Mirum Pharmaceuticals, Inc.
Enrolling: Male and Female Patients
IRB Number: AAAU4380
U.S. Govt. ID: NCT04663308
Contact: Transplant Clinical Research Center: / tcrcstudyreferral@cumc.columbia.edu
Additional Study Information: The purpose of this clinical research study is to learn more about the use of the investigational study drug, volixibat, for the treatment of pruritus (itching) associated with primary sclerosing cholangitis or PSC. Volixibat is a drug that is designed to lower circulating bile acid levels may lead to the itching in patients with PSC. Eligible patients will be randomly assigned to volixibat or to placebo for 28 weeks. This is a double-blind study, so the study doctors and participants will not know to which arm the participants are assigned. After completing 28 weeks of treatment, if eligible, participants may receive "open-label" volixibat in the Long-Term Extension period, which will last least 2 years. If you have any questions regarding this study, please contact the Transplant Clinical Research Center (TCRC).
Investigator
Mercedes Martinez, MD
Do You Qualify?
Are you or your child at least 12 years old? Yes No
Do you or your child have a diagnosis of Primary Sclerosing Cholangitis (PSC)? Yes No
Do you or your child experience itch? Yes No
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For more information, please contact:
Transplant Clinical Research Center
tcrcstudyreferral@cumc.columbia.edu

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